NCT07358260

B7-H3.CD28Z.CART in Solid Tumors

A Phase I, Open Label, Dose Escalation, Single Center Study of Autologous B7-H3.CD28Z.CART Cells in Children and Young Adults With Relapsed or Refractory Solid Tumors Expressing B7-H3

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Robbie Majzner · Academic / Other
• Sex: All
• Age: 9 Months – 30 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research study is to test if a new cell therapy (B7-H3.CD28Z.CART / B7-H3 CAR T cells) is safe and effective in treating children and young adults with solid cancers whose tumors have returned or stopped responding to standard treatments (relapsed or refractory) and have been identified with a B7-H3 marker. The names of the treatment interventions used in this study are: * B7-H3.CD28Z.CART / B7-H3 CAR T cells * Fludarabine * Cyclophosphamide

Detailed description

This is a Phase I, open-label, single-center, dose-escalation study testing the safety and effectiveness of a new cell therapy B7-H3.CD28Z.CART / B7-H3 CAR T cells in children and young adult subjects with relapsed and/or refractory solid tumors expressing B7-H3. The B7-H3 protein is found in high levels on many pediatric solid tumors (like neuroblastoma, osteosarcoma, and others), this cell therapy uses genetically altered blood cells as an investigational cell product designed to recognize, bind to and help kill cells that express B7-H3. This is the first time that these specific B7-H3 CAR T cells will be given to humans. There are several other studies using a similar genetically modified version of B7-H3 CAR T cells and other studies have shown that B7-H3 is a safe target. The U.S. Food and Drug Administration (FDA) has not approved B7-H3 CAR T cells as a treatment for any disease. The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, electrocardiograms (ECGs), echocardiograms (ECHOs), bone marrow biopsies and aspirations. It is expected up to 40 people will take part in this research study. Band of Parents a non-profit organization is supporting this research study by providing funding.

Conditions

• Pediatric Solid Tumor
• Neuroblastoma

Interventions

Type	Name	Description
BIOLOGICAL	B7-H3.CD28Z.CART	Modified autologous T cells administered via Intravenous (IV) infusion
DRUG	Fludarabine	Administered intravenously
DRUG	Cyclophosphamide	Administered intravenously

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-12-31
• Completion: 2031-12-31
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study